# K043586: Laser Sys*Stim 540, Model ME 540

- Pathway: 510(k) (Abbreviated)
- Applicant: Mettler Electronics Corp.
- Decided: May 6, 2005 after 129 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001179 (2000). 9 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032231: MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser, Medx Electronics, Inc. (2003) Summary page 1.
- K040729: Solaris D890 Therapy Probe, Dynatronics Corp. (2004) Summary page 1.
- K031329: Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory), Dynatronics Corp. (2003) Summary page 1.

## Most influential descendants
- K113017: Sys*Stim 240 (2012), 9 descendants of its own
- K223802: accufit (2023), 5 descendants of its own
- K233926: accufit (2024), 4 descendants of its own
- K241685: SofWave System (2024), 2 descendants of its own
- K052647: Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base, CLP-275, CLP-55. (2005), 2 descendants of its own

## Indications for use
The Laser Sys*Stim 540, Model ME 540, is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.

Source page: https://510kreport.com/device/K043586
Methodology: https://510kreport.com/methodology